Scale-Up & Process Development

Research & Development of Energy Technologies

Applied R&D in both renewable (e.g. solar, hydrogen) and non-renewable energy systems. * Design and execution of technology pilot projects and prototypes.

Manufacturing & Commercialisation

Botswana’s first electronics plant: assembly, testing and scaling products from lab to market. * Pilot runs and quality assurance * Test jigs and certification support

Specialty Chemicals & Mineral Beneficiation

Clean coal, gasification to fuels/chemicals, carbon nanomaterials, and extraction of base metals & PGMs. Process development & scale-up Catalysis & carbon materials

Gnanomat Pilot Plant Services

The Gnanomat pilot plant can produce a diverse range of materials by means of wet-chemistry techniques such as dispersion, coprecipitation and microemulsion. Laboratory-scale syntheses can be efficiently scaled up in our pilot plant, enabling the production of hundreds of grams of material instead of the milligram quantities typical of laboratory experiments. This ensures a seamless transition from research to industrial-scale production.

Graphene Production via Hyperion Reactor Technology

HydroGraph’s proprietary Hyperion Reactor technology produces the highest performing synthetic graphene in the world. It is modular, scalable and proven to use the lowest amount of energy in the industry while producing no waste.

Technology Transfer

Technology transfer entails transferring product and process knowledge between development and manufacturing from small-scale clinical trials to large-scale commercial production. Jubilant Biosys offers reliable and efficient approach to transfer technology and our clients can leverage our proficiency, agility, and extensive capacities to seamlessly propel a product through all developmental and manufacturing phases. Our dedicated Tech Transfer team with strong technical expertise helps facilitate speed to market as we collaborate with our partners to ensure successful process transfers, anticipating equipment capabilities and ensuring Quality by Design principles. Our expertise includes seamless transition of processes into API manufacturing environments across clinical and commercial scales. Evaluation * Review of technology for transfer * Project scope defined * Approval of scope of work Establishing Technology Transfer Team * Project kick off meeting * Project plan/schedule * Communication structure * Timeline for document review * Change control * Quality agreement Knowledge/Document Transfer * Gap analysis * Technical document review meeting * Analytical method transfer * Process demo batch * Deviation analysis * Quality agreement * Stability studies Process Transfer * EHS assessment * Logistics * Operations * Process hazard analysis * Pre-startup safety review * Training * Process simulation batches * Validation protocols * Master batch records Manufacturing Campaign * Initial manufacturing campaign * Process validation summary report * Continuous improvement recommendations Continuous Improvement * Manufacturing data review * Equipment / process optimization * Process monitoring * Deviation-root cause analysis * Corrective/preventive actions CDMO Tech Transfer Project Team Jubilant Biosys has a group of experienced and qualified Project Managers to support & manage CDMO project from kick-off to close-out. * Experienced Project Manager as single point of contact for entire project life-cycle: team communication, schedule, scope, action, risk and issue escalation management. * Process & tech transfer chemists work on seamless hand-over from R&D familiarization & process optimization (what if studies) to plant scale-up. * Dynochem simulation for plant equipment mapping and unit operation scalability. * Analytical chemist for method development, validation & transfer to plant QC team. * EHS for OEB and PDE classification and HAZOP evaluation. * Plant engineer for equipment train set up & readiness. * QA/QC to ensure GMP documentation, analysis and release. * Supply Chain to ensure supply strategy and robustness. * Regulatory to support customer filing.

Process Research & Development Capabilities

Route scouting, evaluation, finalization (Linear to Convergent) & Proof-of-Concept (PoC). Salt & Polymorph screening. Tech Transfer, GLP / non-GMP, cGMP material supplies for Tox, Preclinical, Phase I-III. Process design, development and optimization. Process safety studies. Development & management of complex multi-step synthesis of APIs having many chiral centers, Chiral separations. Stereoselective synthesis, Low temperature reactions, High Vacuum Distillation, Solid form development- salt and polymorph studies, Bio transformation. High pressure reactions (hydrogenerators, reductive animation etc.), Process Intensification (continuous flow reactions) DoE application, Data generation for process safety evaluation, Kilo Lab(Capacity — 5,10 & 20L, heating range @2000 C& cooling range @-500.

Non-GMP Scale-up

Route scouting, process design and optimization. Salt screening and polymorph studies. Experience: 40 Clients catered in past 3 years, 153 Projects completed in past 3 years & 10 Scale up NCE (Up to 20kg). Synthetic demonstration scale-up manufacturing. Infrastructure: Scale-up hoods to accommodate multiple 20L reactors, 20L jacketed reactors with TCU, Multiple centrifuges & Nutsche filter and Multiple Rotavapor of 20L and 50L capacity.

Process Research & Development

We have comprehensive process research and development (PR&D) and manufacturing capabilities to support the early CMC campaigns of NCE programs. These combined capabilities ensure well-integrated execution of projects into the clinical phase. PR&D Capabilities - Route scouting, process design and optimization. - Development & management of complex multi-step synthesis of APIs having many chiral centers. - Stereoselective synthesis. - Chiral separations. - Bio-transformation. - Solid form development – salt and polymorph studies. - Low temperature reactions. - High Vacuum Distillation. - High pressure reactions (hydrogenations, reductive amination etc). - Process Intensification (continuous flow reactions) DoE application. - Data generation for process safety evaluation Kilo Lab (Capacity – 5,10 & 20L, heating range @ 200°C & cooling range @ -50°C). PR&D: Technologies and Reactions - Complex Multi- Step Synthesis - Pinner Reaction - Alkylation/ Methylation - Gewald Reaction - Reformatsky Reaction - Low Temperature Reactions - Grignard Rxn - Stereo Selective Hydrogenation - 1,3 Dipolar Cycloadditions - Selective Otosylation - Metal Cyanide - Inorganic Fluoride Fluorination - Williamson Ether Synthesis - Pressure Hydrogenation - Aromatization - Nitrations - Prins Reaction - Stereo Selective Synthesis - Quaternization - Reduction / Chiral Reduction - Doebner- Knoevnagel - Chiral Oxazolidinone Formation - Bio-Transformation - Anhydrous Hf Fluorination - Formation of Chiral Bromohydrin - Doe Application - Transesterification - Leuckart Reaction - Amination & Dealkylation - Chiral Separations - Butyl Li Rxn (Up to – 80°C) - Oxidation / Chiral Oxidation - Witting Reaction - Bischler-Nepieralski Cyclization - High Vacuum Distillation - Beckmann Rearrangemen - Hoffmann Bromide - Mannich Reaction - High Pressure Reactions - Claisen Condensation - Fluorine Exchange - Process Intensification - Diazotisation PR&D: Analytical Capabilities - Method development. - Polymorph characterization reaction monitoring support. - Generation of reference / working standards. - Stability studies as per ICH. - Nitrosamines method development & validation. - Forced degradation studies & development. - Impurity profiling and structural elucidation. - Documentation as per GLP/FDA requirements for Technology transfer. - Centre of excellence for Mass Spectrometry. - Genotox potential evaluation. PR&D: Equipment - Reaction Calorimeter - BRM Lasentec - Autoclaves (SS & Hastalloy up to 100 kg/cm 2 pressure) - Rotavapour - Polarimeter - DSC - ICP-MS - Fluid Bed Drier - Spray Dryer - Lyophilizer etc. - Micro Reactors (Labflo and pilot) - Plug Flow Reactors - FT-IR - GC-MS - Prep-HPLC - LC HRMS - NMR - XRD - LC-MS/MS - Ion Chromatograph - Particle size analyzer - Optical microscope - Stability chambers

Scale-up Chemistry

Jubilant Biosys partners with pharmaceutical and biotechnology companies to translate laboratory-scale processes into robust, scalable manufacturing solutions for high-value intermediates and APIs. Our scale-up expertise ensures consistent performance, optimized yields, and controlled impurity profiles across development stages. With a strong focus on process understanding, safety, and reproducibility, we enable seamless progression from early development to pilot and commercial scale. Backed by an integrated R&D and scale-up ecosystem, we support smooth transition from discovery to gram-to-kilogram scale production, enabling faster and more reliable process scale-up. Capabilities * Process development, optimization, and control strategy * Lab-to-pilot and pilot-to-commercial scale-up * Technology transfer and manufacturing readiness * Scale-up from grams to ~25 kg using reactors ranging from 20L to 250L * Robust infrastructure supporting multi-step small-molecule synthesis and early-phase scale-up Key Strengths * Integrated discovery-to-scale-up platform enabling seamless progression across stages * Strong expertise in route scouting, process optimization, and scalable chemistry development * Risk-assessed scale-up supported by structured safety evaluation frameworks * Operations aligned with global quality and safety standards with SOP-driven execution * Flexible collaboration models supporting both FFS and FTE engagements

Process Safety Studies

API process safety is a critical element in our custom API development services and we ensure that our operations are safe and reliable. Our scientific team offers comprehensive API process safety services and a variety of calorimetric and analytical methods to characterize and minimize risk throughout the process, supporting downstream development within our CDMO services. Comprehensive safety evaluation is done once a project is accepted and runs parallel to process development activities to identify both desired and undesired potential material and reaction hazards. Thermal stability testing of the materials and mixtures used in the process is completed using instruments including differential scanning calorimeter (DSC). Our endeavour is to understand specific needs and challenges of our clients and develop customized API process safety solutions based on. * Literature data and calculations * Screening tests * Adiabatic calorimetry * Hazard Evaluation Report for scale up assurance Appropriate engineering controls are adopted prior to batch processing and captured in the Process Hazards Analysis and Process Safety Information report.

Laser marking consultancy and testing

At Keeling & Walker, we work closely with customers to deliver tailored laser marking solutions. Our team provides specialist polymer marking consultancy, backed by in-house laser systems for testing and small-scale trials. Whether you need technical guidance, test batches, or help with complex applications, we're here to ensure optimal marking performance. For challenging projects, we collaborate to develop innovative solutions together.

SUMOstar Advanced Applications (Therapeutic Protein Production)

Many new therapies are now being delivered as genes, mRNA, or AAV-mediated vehicles. Poor expression in prokaryotic and eukaryotic hosts is the primary cause of a lack of efficacy of these therapies. Clinical-scale production of functional biotherapeutics such as proteins used in CAR-T therapy and vaccine candidates routinely faces challenges of expression quantity, misfolding, incorrect localization, degradation in the host cell, and HIGH costs. However, clinical-scale production remains critical for successful therapeutic outcomes. To overcome these challenges, we developed the SUMOstar™ tag, a modified version of the SUMO fusion platform ideal for mammalian expression due to its resistance to endogenous SUMO proteases found in all eukaryotic systems. The SUMOstar™ tag remains tethered to the protein throughout the purification process. Precise C-terminal removal of the tag simply requires end user-induced cleavage by engineered SUMOstar™ proteases. The native N-terminal residues of the protein are completely preserved following cleavage, which is particularly important for researchers seeking biologically active cytokine-based therapeutic strategies. Service Highlights: Large-scale production of biotherapeutics; Precise, inducible, tag removal to preserve N-terminal residues for biological activity (e.g. cytokines); Enhanced secretion of drug targets such as recombinant antibodies, insulin, growth hormones, and stimulating factors